NCT00989209

Brief Summary

Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
Last Updated

October 5, 2009

Status Verified

October 1, 2009

Enrollment Period

11 months

First QC Date

October 2, 2009

Last Update Submit

October 2, 2009

Conditions

Facial Paralysis

Keywords

facial paralysisasymmetrymyofunctional therapybotulinum toxinfacial evaluation

Outcome Measures

Primary Outcomes (1)

  • Clinical score

    2 months

Secondary Outcomes (1)

  • Facial Disability Index (self-report instrument)

    2 months

Study Arms (2)

A: myofunctional prior to botulinum

ACTIVE COMPARATOR

All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group A, botulinum toxin was applied after myofunctional therapy.

Drug: Botulinum Toxin Type AProcedure: myofunctional therapy

B: myofunctional after botulinum

ACTIVE COMPARATOR

All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group B, botulinum toxin was applied before myofunctional therapy.

Drug: Botulinum Toxin Type AProcedure: myofunctional therapy

Interventions

Botulinum Toxin Type ADRUG

All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U.

Also known as: BOTOX (Allergan)
A: myofunctional prior to botulinumB: myofunctional after botulinum
myofunctional therapyPROCEDURE

All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.

A: myofunctional prior to botulinumB: myofunctional after botulinum

Eligibility Criteria

Age16 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • facial paralysis with more than 2 years elapsed since the onset of symptoms
  • surgically treated for reanimation at least 12 months before
  • static and/or dynamic facial asymmetry causing aesthetic concern

You may not qualify if:

  • spastic paralysis
  • serious systemic or neuromuscular diseases
  • cognition impairment
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • Salles AG, Toledo PN, Ferreira MC. Botulinum toxin injection in long-standing facial paralysis patients: improvement of facial symmetry observed up to 6 months. Aesthetic Plast Surg. 2009 Jul;33(4):582-90. doi: 10.1007/s00266-009-9337-9. Epub 2009 Mar 28.

    PMID: 19330369BACKGROUND

MeSH Terms

Conditions

Facial Paralysis

Interventions

Botulinum Toxins, Type AMyofunctional Therapy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsRehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesDentistry

Study Officials

  • Alessandra G Salles

    University of Sao Paulo General Hospital

    STUDY DIRECTOR

  • Marcus C Ferreira

    University of Sao Paulo General Hospital

    STUDY CHAIR

  • Paula N Toledo

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

  • Claudia F Andrade

    University of Sao Paulo General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

January 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2006

Last Updated

October 5, 2009

Record last verified: 2009-10

Locations

BR(1)